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Trial NCT06772623

Study to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations

Phase
Phase 1/2
Sponsor
AbbVie
Conditions
Non Small Cell Lung Carcinoma; c-MET
Ages
18+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

Inclusion Criteria: * Must have histologically documented non-squamous (NSq) non small cell lung carcinoma (NSCLC) that is locally advanced or metastatic will be enrolled into the study. * Must have measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1. * For Part 1, participants must have had no more than 1 systemic therapy for advanced disease including platinum-based chemotherapy or an immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy), or appropriate targeted therapy for an actionable gene alteration, if applicable, for epidermal growth factor receptor (EGFR) wild-type (WT) NSq NSCLC. * For Part 2, participants must have no prior systemic therapy for advanced disease, no known actionable genomic alteration. * Must have documented programmed death ligand 1 (PD-L1) status. * For Part 2, participant must have evaluable c-Met immunohistochemistry (IHC) result per central testing prior to randomization. * Must have adequate organ function. Exclusion Criteria: * Known uncontrolled metastases to the central nervous system.Brain metastases * History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis on screening chest computed tomography (CT) scan.

Restrictions found (1)

Recruiting in Massachusetts

  • Dana-Farber Cancer Institute /ID# 278417 · Boston, Suffolk County